Effectiveness of Two Sealant Materials Over 5 Years
The purpose of this study is to assess the effectiveness of a new hydrophilic sealant (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evidence Based Effectiveness of Pit and Fissure Sealants Applied By Students and Paediatric Dentists After (Three) Five Years.|
- Changes in retention of sealants from baseline to five years [ Time Frame: Baseline and every year (baseline to five years) ] [ Designated as safety issue: No ]The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every year for 5 years.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Ultraseal Sealant
Both Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients.
Other: Ultraseal Sealant
This is a newly developed hydrophilic sealant material.
Other Name: Ultraseal XT HydroOther: Ultraseal Sealant
This is a previously existing hydrophobic sealant material.
Other Name: Ultraseal XT Plus
The new hydrophobic sealant material eliminates the step of prime and drying the tooth which prevents from over drying the tooth surface and decreases chair time, which is important when working with children. The null hypothesis is that there is no difference between the materials. The alternate hypothesis is that the Ultraseal XT Hydro is a better material.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01710865
|Contact: Dr. Sahza Hatibov-Kofman, D.D.S.,FRCD||5196612111 ext firstname.lastname@example.org|
|Children's Clinic at Western University||Not yet recruiting|
|London, Ontario, Canada, N6A2S9|
|Contact: Dr. Sahza Hatibov-Kofman, D.D.S.FRCD (519) 661-2111 ext 86131 email@example.com|
|Principal Investigator: Dr. Sahza Hatibov-Kofman Hatibov-Kofman, D.D.S.FRCD|
|Principal Investigator:||Dr. Sahza Hatibov-Kofman, D.D.S.FRCD||Division of Orthodontics and Paediatric Dentistry|